Identity
- Trade Name
- O-Two FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. It provides eight sizes: 40MM, 50MM 60MM, 70MM, 80MM, 90MM, 100MM AND 110MM. The bit block is rigid and identified with color coding. The smooth surface and rounded tip can improve patient comfort. O-Two Guedel Airway is manufactured with 100% Polyethylene (PE) which is latex free and for single use only. The size of 01AM3008 is 110 mm. FDA UDI
- Model / Reference
- 01AM3008U FDA UDI
- Description
- O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. It provides eight sizes: 40MM, 50MM 60MM, 70MM, 80MM, 90MM, 100MM AND 110MM. The bit block is rigid and identified with color coding. The smooth surface and rounded tip can improve patient comfort. O-Two Guedel Airway is manufactured with 100% Polyethylene (PE) which is latex free and for single use only. The size of 01AM3008 is 110 mm. FDA UDI
Identifiers
- Catalog Number
- 01AM3008 FDA UDI
- Primary DI / UDI-DI
- 07540195039087 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Oropharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 110 Millimeter FDA UDI
Category: Oropharyngeal airway, single-use
O-Two by O-Two Medical Technologies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI 29ed7d69-df88-4734-b230-d783e1d8a096 37 fields · synced May 30, 2026